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Conformity assessment of medical devices

Certificate of Accreditation №1О101

Orders by the Ministry of Economic Development and Trade of Ukraine

since 29.08.2014 No. 1044 and since 21.07.2015 No. 846

Within the European integration, Ukraine harmonizes Technical regulations system with standards and principles of the European Union.

Especially sales and use of medical devices in Ukraine is allowed after confirmation of their conformance to one of three Technical regulations developed from conforming EU directives:

  • Technical regulations for medical devices;
  • Technical regulations for IVD medical devices;
  • Technical regulations for active implantable medical devices.

SE “UMCC” is authorized body for medical devices conformity assessment to the requirements of all three Technical regulations.

Conformity assessment of medical devices starts with filing the application.

 

Document Title Download (language)
Application for Conformity assessment of medical devices to Technical regulations. Укр Рус Eng
Appendix to Application for Conformity assessment of medical devices to Technical regulations. Укр Рус Eng
Appendix to Application for Conformity assessment of medical devices to Technical regulations for IVD medical devices. Укр Рус Eng
Application for Conformity assessment of medical devices to Technical regulations due to changes. Укр Рус Eng
Questionnaire for Conformity assessment of medical devices to Technical regulations. Укр Рус Eng
Example of filling in the Application for Conformity assessment of medical devices to Technical regulations. Укр Рус Eng
Application for recognition of conformity assessment of medical devices to Technical regulations. Укр Рус Eng

 

Conformity assessment procedures can be divided into two groups:

  • those that are performed by manufacturer;
  • those that require participation of the authorized body.

Manufacturers assess independently the conformance of medical devices of potential usage risk I (non-aseptic, without measurement function) to Technical regulations for medical devices; and for IVD medical devices that are not referred to A, B lists and are not designed for self-control. In all other cases the assessment must be performed by an authorized body.

SE “UMCC” assesses the conformance of medical devices as under the Appendixes to regulations providing manufacturer’s quality management system audit, and under those providing expert examination of the documents and performance of tests in Ukraine in the in-house or involved laboratory without departure to manufacturer.

For those manufacturers, which perform the conformation assessment independently SE “UMCC” can perform inspection of technical files and declaration of conformance.

For supplementary call us on phone numbers or turn to us in any other way, which is convenient for you.

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